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Quality Control of Qualitative Tests for Medical Laboratories

Quality Control for Qualitative Methods in Medical Laboratories
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Quality Control for Qualitative Methods in Medical Laboratories

The book seeks to answer questions important to laboratory practice such as:
̶ What is required, and what is not, in the ISO standards?
̶ Which are the most significant sources of uncertainty?
̶ What is the similarity and difference between “Uncertainty Approach,” and “Error Approach”?
̶ Which models do we use to compute both methodologies?
̶ And which models to determine conditional accuracy, delta values, and seronegative window period?
̶ Which are the best models to compute the agreement of binary results?
̶ How do we identify “the best” cutoff point?

This book addresses the need for a book dedicated to quality control of qualitative tests

Table of Contents


Chapter 1 - ISO compliance

Chapter 2 - Significant causes of uncertainty in qualitative tests

Chapter 3 - Measurement uncertainty and analytical total error in qualitative tests

Chapter 4 - Performance of binary classification tests

Chapter 5 - Agreement of binary classification tests

Chapter 6 - Computation of the cutoff for "in-house" and modified tests

Chapter 7 - Internal quality control and external quality assessment

The book is written primarily for the laboratorian and aims to substantiate the selection of the best statistical tools
considering the intended use of the qualitative tests’ results (fitness for purpose)
The purpose of the book is to answer most of qualitative tests QC questions in a three-pronged vision: the statistical, the clinical and the regulatory vision

• More than 20 examples based on real-world data are presented
• The book includes several cases of immunoassays and NAT for screening in virology, ABO blood test, HLA typing, and karyotype tests
• The statistical quality control tools applied to the examples are generic; they can be used in most of the qualitative tests
• Approx. 200 pages printed on coated paper (couché) 90 grams; cover printed on 170 gram coated paper with soft-touch plastic coating; 2mm hard card cover

PLEASE NOTE: This book ships from Portugal.  For standard orders to the US, a registered parcel will take approximately 5 business days to arrive.